Senior Validation Expert

18 hours ago

Malappuram, Kerala, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Validation Trainer Position

We are seeking an experienced Senior Validation Trainer to support global validation projects remotely. The ideal candidate will ensure compliance with regulatory requirements, including GxP standards.

Key Responsibilities:
  • Lead and execute validation activities for equipment, utilities, and systems in compliance with regulatory and industry standards.
  • Develop and review validation documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Manage and implement validation master plans and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
Required Qualifications:
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on validation experience in the pharma and/or medical device industries.
  • Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10, ISO 13485).
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
Benefits:
  • Global validation project support.
  • Compliance with regulatory requirements.
  • Validation master plan implementation.
  • Data integrity assessments.
  • 21 CFR Part 11 compliance.
What We Offer:
  • Opportunity to work on global validation projects.
  • Chance to develop and review validation documentation.
  • Collaboration with cross-functional teams.
  • Remote FAT/SAT support and data review.

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